Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

thornton & ross ltd - zinc oxide; castor oil; cetostearyl alcohol; beeswax white; arachis oil - cutaneous ointment - 75mg/1gram ; 500mg/1gram ; 20mg/1gram ; 100mg/1gram ; 305mg/1gram

USA - engelska - NLM (National Library of Medicine)

endo usa, inc. - testosterone undecanoate (unii: h16a5vct9c) (testosterone - unii:3xmk78s47o) - testosterone undecanoate 250 mg in 1 ml - aveed is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. - primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [fsh], luteinizing hormone [lh]) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum concentrations but have gonadotropins in the normal or low range. aveed should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of pome and anaphylaxis. limitations of use - safety and efficacy of aveed in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. - safety and efficacy of aveed in males less than 18 years old have not been established [see use in specific populations ( 8.4 )]. aveed should not be used in any of the following patients: - men with carcinoma of the breast or known or suspected carcinoma of the prostate [see warnings and precautions (5.3)]. - women who are pregnant. testosterone can cause virilization of the female fetus when administered to a pregnant woman [see use in specific populations (8.1, 8.2)] .  - men with known hypersensitivity to aveed or any of its ingredients (testosterone undecanoate, refined castor oil, benzyl benzoate). risk summary aveed is contraindicated in pregnant women. testosterone is teratogenic and may cause fetal harm based on data from animal studies and its mechanism of action [see contraindications (4) and clinical pharmacology (12.1)] . exposure of a female fetus to androgens may result in varying degrees of virilization. in animal development studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. these studies did not meet current standards for nonclinical development toxicity studies. data animal data in developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis. testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. structural impairments observed in females included increased anogenital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen. increased pituitary weight was seen in both sexes. testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. hypertension was observed in pregnant female rats and their offspring exposed to doses approximately twice those used for testosterone replacement therapy. risk summary aveed is not indicated for use in females. infertility during treatment with large doses of exogenous androgens, including aveed, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [see warnings and precautions (5.9)] , possibly leading to adverse effects on semen parameters including sperm count. reduced fertility is observed in some men taking testosterone replacement therapy. testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids [see drug abuse and dependence (9.2)] . with either type of use, the impact on fertility may be irreversible. safety and effectiveness of aveed in pediatric patients less than 18 years old have not been established.  improper use may result in acceleration of bone age and premature closure of epiphyses. there have not been sufficient numbers of geriatric patients in controlled clinical studies with aveed to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. of the 153 patients enrolled in the pivotal clinical study utilizing aveed, 26 (17.0%) were over 65 years of age. additionally, there are insufficient long-term safety data in geriatric patients to assess the potentially increased risk of cardiovascular disease and prostate cancer. geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of bph [see warnings and precautions (5.3)] . no studies were conducted in patients with renal impairment. no studies were conducted in patients with hepatic impairment. aveed contains testosterone, a schedule iii controlled substance in the controlled substances act. drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. abuse and misuse of testosterone are seen in male and female adults and adolescents.  testosterone, often in combination with other anabolic androgenic steroids (aas), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. there have been reports of misuse of men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. abuse-related adverse reactions serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility, and aggression. the following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. the following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities. the following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. behaviors associated with addiction continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors: - taking greater dosages than prescribed - continued drug use despite medical and social problems due to drug use - spending significant time to obtain the drug when supplies of the drug are interrupted - giving a higher priority to drug use than other obligations - having difficulty in discontinuing the drug despite desires and attempts to do so - experiencing withdrawal symptoms upon abrupt discontinuation of use physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

Irland - engelska - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - refined olive oil + refined soybean oil ; alanine ; arginine ; aspartic acid ; glutamic acid ; glycine; histidine ; isoleucine ; leucine ; lysine ; methionine; phenylalanine ; proline ; serine ; threonine ; tryptophan, l- ; tyrosine ; valine ; sodium acetate trihydrate; sodium glycerophosphate, hydrated ; potassium chloride; magnesium chloride hexahydrate ; calcium chloride dihydrate ; glucose monohydrate - emulsion for infusion - unknown - combinations

Irland - engelska - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - refined olive oil + refined soybean oil ; alanine ; arginine ; aspartic acid ; glutamic acid ; glycine; histidine ; isoleucine ; leucine ; lysine ; methionine; phenylalanine ; proline ; serine ; threonine ; tryptophan, l- ; tyrosine ; valine ; glucose monohydrate - emulsion for infusion - unknown - combinations

Irland - engelska - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - refined olive oil + refined soybean oil ; alanine ; arginine ; aspartic acid ; glutamic acid ; glycine; histidine ; isoleucine ; leucine ; lysine ; methionine; phenylalanine ; proline ; serine ; threonine ; tryptophan, l- ; tyrosine ; valine ; glucose monohydrate ; sodium acetate (as trihydrate) ; sodium glycerophosphate, hydrated ; potassium chloride ; magnesium chloride hexahydrate ; calcium chloride dihydrate - emulsion for infusion - 7g/l / 1140kcal/l - combinations

Irland - engelska - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - refined olive oil + refined soybean oil ; alanine ; arginine ; aspartic acid ; glutamic acid ; glycine; histidine ; isoleucine ; leucine ; lysine ; methionine; phenylalanine ; proline ; serine ; threonine ; tryptophan, l- ; tyrosine ; valine ; glucose monohydrate - emulsion for infusion - unknown - combinations

Irland - engelska - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - refined olive oil + refined soybean oil ; alanine ; arginine ; aspartic acid ; glutamic acid ; glycine; histidine ; isoleucine ; leucine ; lysine ; methionine; phenylalanine ; proline ; serine ; threonine ; tryptophan, l- ; tyrosine ; valine ; glucose monohydrate ; sodium acetate trihydrate ; sodium glycerophosphate, hydrated ; potassium chloride; magnesium chloride hexahydrate ; calcium chloride dihydrate - emulsion for infusion - 9g/l / 1070kcal/l - combinations

Irland - engelska - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - refined olive oil + refined soybean oil ; alanine ; arginine ; aspartic acid ; glutamic acid ; glycine; histidine ; isoleucine ; leucine ; lysine ; methionine; phenylalanine ; proline ; serine ; threonine ; tryptophan, l- ; tyrosine ; valine ; sodium acetate trihydrate; sodium glycerophosphate, hydrated ; potassium chloride; magnesium chloride hexahydrate ; calcium chloride dihydrate ; glucose monohydrate - emulsion for infusion - 4gl/700kcal/l - combinations

Irland - engelska - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - refined olive oil + refined soybean oil; alanine; arginine ; aspartic acid; glutamic acid ; glycine; histidine; isoleucine; leucine ; lysine; methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine; valine; sodium acetate trihydrate ; sodium glycerophosphate, hydrated; potassium chloride; magnesium chloride hexahydrate; calcium chloride dihydrate; glucose monohydrate - emulsion for infusion - 5g/l/ 990kcal/l - solutions for parenteral nutrition; combinations

Irland - engelska - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - refined olive oil + refined soybean oil; alanine; arginine ; aspartic acid; glutamic acid ; glycine; histidine; isoleucine; leucine ; lysine; methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine; valine; glucose monohydrate - emulsion for infusion - 7g/l/1140kcal/l - solutions for parenteral nutrition; combinations